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Open Access 01-12-2017 | Study protocol

Magnetic resonance imaging for cerebral lesions during minimal invasive mitral valve surgery: study protocol for a randomized controlled trial

Authors: Cristina Barbero, Davide Ricci, Erik Cura Stura, Augusto Pellegrini, Giovanni Marchetto, Suad ElQarra, Massimo Boffini, Roberto Passera, Maria Consuelo Valentini, Mauro Rinaldi

Published in: Trials | Issue 1/2017

Abstract

Background

Recent data have highlighted a higher rate of neurological injuries in minimal invasive mitral valve surgery (MIMVS) compared with the standard sternotomy approach; therefore, the role of specific clamping techniques and perfusion strategies on the occurrence of this complication is a matter of discussion in the medical literature.

The purpose of this trial is to prospectively evaluate major, minor and silent neurological events in patients undergoing right mini-thoracotomy mitral valve surgery using retrograde perfusion and an endoaortic clamp or a transthoracic clamp.

Methods/design

A prospective, blinded, randomized controlled study on the rate of neurological embolizations during MIMVS started at the University of Turin in June 2014. Major, minor and silent neurological events are being investigated through standard neurological evaluation and magnetic resonance imaging assessment. The magnetic resonance imaging protocol includes conventional sequences for the morphological and quantitative assessment and nonconventional sequences for the white matter microstructural evaluation. Imaging studies are performed before surgery as baseline assessment and on the third postoperative day and, in patients who develop postoperative ischemic lesions, after 6 months.

Discussion

Despite recent concerns raised about the endoaortic setting with retrograde perfusion, we expect to show equivalence in terms of neurological events of this technique compared with the transthoracic clamp in a selected cohort of patients. With the first results expected in December 2016 the findings would be of help in confirming the efficacy and safety of MIMVS.

Trial registration

ClinicalTrials.gov, Identifier: NCT02818166. Registered on 8 February 2016 – trial retrospectively registered.

Available only for authorised users

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Title: Magnetic resonance imaging for cerebral lesions during minimal invasive mitral valve surgery: study protocol for a randomized controlled trial
Authors: Cristina Barbero
Davide Ricci
Erik Cura Stura
Augusto Pellegrini
Giovanni Marchetto
Suad ElQarra
Massimo Boffini
Roberto Passera
Maria Consuelo Valentini
Mauro Rinaldi
Publication date: 01-12-2017
Publisher: BioMed Central
Published in: Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-017-1821-y

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Magnetic resonance imaging for cerebral lesions during minimal invasive mitral valve surgery: study protocol for a randomized controlled trial

Abstract

Background

Methods/design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

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